Calendario›REGN›Dupilumab

Dupilumab

A Study to Assess the Efficacy and Safety of Dupilumab in Participants With Severe Atopic Dermatitis (AD) That Are Not Controlled With Oral Cyclosporine A (CSA) or for Those Who Cannot Take Oral CSA Because it is Not Medically Advisable

Ensayo de REGENERON PHARMACEUTICALS, INC. en Dermatitis atopica.

Más ensayos de: Dermatitis atópica.

Fase

Fase 3

Estado

Completado

Participantes

325

previstos

Centros

73

Fin del objetivo primario

ene 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2016.

Qué mide

Percentage of Participants With Eczema Area and Severity Index (EASI) 75 (≥75% Improvement From Baseline) at Week 16 (del registro, en inglés) (inicio y semana 16)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe main objective of the trial is to evaluate the efficacy of 2 dose regimens of dupilumab compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral Cyclosporine A (CSA), or when this treatment is currently not medically advisable. The secondary objective is to assess the safety and tolerability of 2 dose regimens of dupilumab compared to placebo, administered with concomitant TCS, in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when this treatment is currently not medically advisable.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02755649), actualizada en ago 2020.